Actively Recruiting
A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-07-24
800
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, active-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets compared with dapagliflozin in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.
CONDITIONS
Official Title
A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects between 18 and 75 years of age (inclusive).
- Diagnosed with type 2 diabetes mellitus for at least 3 months.
- Treated with a stable dose of metformin (at least 1500 mg/day or maximally tolerated dose not less than 1000 mg) for at least 8 weeks prior to screening and stable for at least 12 weeks prior to randomization.
- HbA1c between 7.5% and 11.0% at screening and prior to randomization.
- Body mass index (BMI) between 19.0 and 40.0 kg/m2 inclusive.
- Female participants of childbearing potential and male participants must agree to use highly effective contraception from signing consent until 30 days (female) or 90 days (male) after final dose.
- Able to understand and comply with protocol requirements, maintain same diet and exercise habits, complete the trial, and provide informed consent.
You will not qualify if you...
- Diagnosed with type 1 diabetes, special types of diabetes, or gestational diabetes.
- Experienced acute diabetes complications (e.g., ketoacidosis, lactosidosis, hyperosmolar coma) within 6 months before consent.
- Known personal or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type II.
- History of pancreatitis, pancreatic injury, or high risk for pancreatitis; symptomatic gallbladder disease needing treatment during the trial (prior gallbladder removal may be allowed).
- Conditions affecting gastric emptying or nutrient absorption (e.g., surgery, reflux disease, pyloric obstruction, irritable bowel syndrome).
- Within 3 months before screening, history of unstable angina, severe heart failure, myocardial infarction, coronary interventions, severe arrhythmias, or stroke.
- Proliferative diabetic retinopathy or diabetic maculopathy requiring treatment.
- Known liver diseases including active hepatitis B or C, or primary biliary cholangitis.
- Use of strong CYP3A4 or P-gp inhibitors or inducers not discontinued before trial.
- Use of glucose-lowering medications other than metformin within 4 weeks before consent.
- Use of GLP-1 analogues within 3 months before consent or prior discontinuation due to safety or efficacy.
- Pregnant or breastfeeding.
- Known severe drug allergies or hypersensitivity to SGLT-2 inhibitors or GLP-1 receptor agonists.
- Participation in another clinical trial within 3 months before consent.
- Any other condition deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yueyang People's Hospital
Yueyang, Hunan, China, 414000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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